Status:

COMPLETED

Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

Lead Sponsor:

Biosearch S.A.

Conditions:

Mastitis

Breast Milk

Eligibility:

FEMALE

18-45 years

Phase:

NA

Brief Summary

The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of mastitis. Bacterial load and...

Detailed Description

Pregnancy and lactation are important moments for the child that will determine their development and future health. One of the key processes is when the microbiota is established in the baby. Contami...

Eligibility Criteria

Inclusion

  • Normal development of pregnancy
  • Single fetus pregnancy
  • Be in week 28-32 of pregnancy
  • Intention to breastfeed the child for 16 weeks

Exclusion

  • Having a breast disease that hinders or prevents breastfeeding
  • Have been taking probiotic supplements 2 weeks before starting the study
  • Have a low expectation of adherence to the study protocol

Key Trial Info

Start Date :

April 15 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 31 2024

Estimated Enrollment :

480 Patients enrolled

Trial Details

Trial ID

NCT04032899

Start Date

April 15 2019

End Date

May 31 2024

Last Update

February 6 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Hospital Costa del Sol

Marbella, Andalusia, Spain, 29603

2

Hospital Campus de la Salud

Granada, Grabada, Spain, 18007

3

Hospital Virgen de las Nieves

Granada, Granada, Spain, 18014

Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis | DecenTrialz